THI TU DUYEN BUI

AREAS OF EXPERTISE:

Quality Assurance and Quality Control Management Onsite Operations

Supply Chain cooperation CAPA, Nonconformance, Deviation

FSSC/ HACCP/GMP/ISO9001-14001-22000/OHSAS18001/ISO13485 Production Process Control

Food safety, Quality Regulation Compliance Customer Service/ Satisfaction

21 CFR Part 820, 211, 210,111, 110 / FDA/ CDPH/ cGMP Project Management

External/ Internal audit expertise

Resource Allocation and Administration

Seeking advancement opportunities as a Quality Systems professional. Quality professional with 20+ years of experiences in medical device/ pharmaceuticals/ food and beverage/ dairy and FMCGs industries, utilizing expertise and knowledge in implementing and managing effective quality improvement processes and structures in a corporate and regulated environment.

15+ years in Quality Systems role, leading CAPA, nonconformance, root cause analysis and actions taken. Highly focused and result-oriented, deadline driven quality/ compliance process and products related projects.

PROFESSIONAL EXPERIENCE

Spectrum Chemicals Manufacturing Corp. Jan 2022 – Nov 2023

Gardena, CA

Quality Assurance Department – Sr. Specialist

Assist in assuring that Spectrum operates in accordance to current Good Manufacturing Practices with the applicable parts of 21 CFR, parts 210 and 211 and parts 110 and 111 of the Code of Federal Regulations, respectively and in compliance to ISO 9001:2015 Quality standards

Host Customer Quality System Audits and assist in Regulatory Inspections (60+ audits per year). Responsible for conducting the CAPA for audit findings and suggestion for system improvements.

Maintain Customer Change Control Program and Notification Support to affected parties

Coordinate with customers with various quality documentation requests regarding Spectrum’s Quality Management System.

Coordinate with Spectrum Sales team by providing quality-related documentation as requested.

Assist the organizations to formulate quality standards and regulations for the product produced. Analyze the data gathered and plan accordingly to improve product quality.

Batch Records review, release and management.

Lead and carry out corrective and preventive actions (CAPA) to resolve the issue to ensure quality of our products and work closely with multi-departments to drive process improvements through CAPA execution.

Determine actions necessary to eliminate recurrence of customer complaints. Investigate all open customer complaints.

Complete Customer Quality Surveys & Questionnaires

Coordinate Quality / Technical data requests: such as Customer Spec Sheets, or Certificates of Origin, Stability Data, GMP Certifications, etc.

Perform Internal Quality Audits, Mock FDA Audit.

Ensure compliance to FDA Quality Systems Regulations, 21 CFR 211, 210, 111, 110, ISO 9001, ISO14001, cGMP

Review and approve the Out Of Specification reports, Deviations

Maintain and continual development of Scientific Documentation/Quality Response Package Maintain Supplier Qualification Program

a)Evaluating supplier self audit questionnaire

b)Performing site quality system audits

c)Establishment of Quality Agreements/Clauses

Carl Zeiss Meditec Production, LLC. May 2020 – Dec 2021

Ontario, CA

Quality Management/ Quality Control Department – Sr. Lead

To maintain Quality Control practices in 2nd shift in adherence to the Food and Drug Administration (FDA) STANDARDS FOR THE Quality System Regulation and to the ISO 13485 standards. To ensure the completeness and compliance of documents, records

Being involved in the CAPA/ Deviation by investigating and problem solving issues that may include the use of 5W, Ishikawa, SPC, AQL and other evaluation/ measurement methods

Support departments in their efforts to produce a high quality, cost effective products

To review and maintaining all associated documentation, priority lists, performance trending which relate to product release and final packaging

To corporate internal auditing program and the review of various processes to aid, control and maintain quality product in accordance with FDA and other agency regulations

Maintain and improve quality awareness to keep rejects to an acceptable level

Ensure compliance to FDA Quality Systems Regulations, 21 CFR 820, ISO 13485.

Primary CAPA support during internal and external audits

Robinson Pharma INC Jan 2019 – May 2020

Santa Ana, CA

Quality Assurance Supervisor

Responsible for reviewing and approving pertinent documents, records and reports such a Manufacturing Batch Records, Forms, etc. against Standard Operating Procedures (SOPs) and compliance to procedures based on regulatory requirements and internal guidelines

Perform ongoing daily departmental activities related to deviation management

Responsible for initiating, tracking, investigating and completing documentation associated with exceptions and corrective actions resulting from process, equipment and facility deviations for the areas as needed.

Responsible for technical review of Non –Conformance investigations including deviations and Out Of Limits (OOLs).

Responsible for leading root cause investigation, reviewing and approving CAPAs and Nonconformance reports

Manage activities of self in achieving defined Quality goals in an efficient, accurate and timely manner.

Support in-plant audit ready status efforts for assigned areas and assist other areas within the facility in understanding FDA, SQF, NSF

Ensure compliance to FDA Quality Systems Regulations, 21 CFR 211, 210, 111, 110, cGMP, NSF, SQF requirements.

Support with Internal and External Quality audits/assessments and provide ongoing feedback related to quality issues.

Support and drive continuous improvements consistent with the divisional strategy and ensure compliance to all applicable state, federal and international regulations

HCR ManorCare Health Services June 2018 – December 2018

Fountain Valley, CA Certified Nursing Assistant

Stanley Healthcare March 2018 – June 2018

Westminster, CA

Certified Nursing Assistant

QBICS CAREER COLLEGE, Jan 2018 – Feb 2018

Santa Ana, CA

Nursing Assistant Program.

Certification for Nursing Assistant.

Certification for CPR and AED.

SuntoryPepsico Vietnam Co, Ltd., August 2013 – April 2017

Hochiminh City, Vietnam

Quality Control Department – Manager

Ensuring the overall quality of ingredients and finished products in accordance with Company’s Standard so

as to uphold trademark integrity.

Responsible for managing day and night shifts; union and non-union employees and developing a team of supervisors

Responsible for leading the development of manufacturing processing standards; organize and supervise applications of the comprehensive quality and food safety programs across SuntoryPepsico Vietnam.

Providing training, implementation and adherence to develop process capabilities and advanced quality planning deliverables including the all systems, processes and procedures; ensuring continuity of business according to SuntoryPepsico Vietnam, customer and regulation expectations

Ensuring the compliances with Food safety and Health safety internal and external regulations.

Lead Food Safety and Food Defense Team; HACCP/ GMP/ISO management systems

Formulate quality policies, programs and provide guidance, feedback to supply chain; these programs will be designed to meet operational plans, customer expectations and regulatory.

Leading CAPA executions and Nonconformance control process.

Akzo Nobel Paints Vietnam Ltd., May 2010 – August 2013

Duong city, Vietnam

Quality Assurance and Quality Control Department – Manager

Plan and drive the implementation of the Quality Management System and quality improvement projects to assure its compliance with Government regulations/ requirements and Corporate Standards; to create the competitiveness of the Business in Quality Assurance.

Conduct, steer, monitor and control the execution of the Quality Management System

Implement and ensure the preventive and corrective actions actively and effectively

Assure the Supplier and Toller’s reliability and performance relating too quality assurance

Drive Quality Maintenance in accordance with LEAN Management system in Operations

Implement the Corporate Safety system and applied ISO14000-18000

FrieslandCampina Vietnam Co. Ltd., Dec 2007 – May 2010

Duong, Vietnam

Quality Assurance Manager

Found and manage highly successful in operations which is mainly for Dairy Foods (Infant formula, Follow-on formula, Growing-up formula, MUM, Specialties, others)

Responsible for auditing all applied systems: Food safety, Quality, Environment, Occupational, Personal Hygiene

Responsible for auditing all Suppliers: Raw materials, Packaging materials, Ingredients materials

Closely contact and coordinate with the Head Quarter to uniform all specifications, standards, regulations

SC Johnson & son Co. Ltd., July 2005 – Nov 2007

Binh Duong, Vietnam

Quality Assurance/Control Manager

Responsible for execution the in-house operations

Responsible for auditing all applies Quality, Safety, Environment Management systems

Ensure quality improvements in conventional processes

Implement the customer complain procedure effectively

Coordinate to set up and maintain the company SHE Roadmap in accordance with the Head Quarter guidance

Unilever Vietnam Co. Ltd., Oct 1997 – July 2005

Hochiminh, Vietnam

Quality Assurance and Quality Control Department.

QA Manager Assistant

Found and manage highly successful in-house and out-door operations which are mainly for Personal Care (Skincare, Haircare, Personal Wash); Laundry – Homecare, Household care (Hygienic cleaner)

Establish and successfully implemented the division’s rotation plans

Responsible for auditing all applied management systems: Quality – Consumer Safety – Environment –

Safety and Occupational)

Take responsibility as a SHE Marshall in QA and R&D departments

Responsible for a role as SHE Company Committee

Implement TPM to increase productivity, efficiency and minimize losses, wastages in Business

Implement new methods to track and improve profitability

Conduct quality audits and appraisal systems for all Third Party manufacturers, in all applied management systems

UIC JT Nov 1994 – Oct 1997

Dong Nai Province, Vietnam

Laboratory

Maintain inventory control system; monitor and approve incoming deliveries

Manage daily operations, schedule staff assignment

EDUCATION

USA Equivalent of Bachelor of Science in Chemistry

CQE - ASQ

Bachelor of Science Degree in Analytic Chemistry (1990 – 1994)

Science of Nature University, Hochiminh city, Vietnam

Medical Billing and Coding – Associate degree (2019) Ultimate Medical Academy

Tampa, FL 33607

ISO9001 Internal Auditor Certified, ISO22000 Lead Auditor, ISO14001/ OHSAS18001 Internal Auditor Certified, AIB Pest Management Certified

Nursing Assistant Program.

QBICS CAREER COLLEGE, 1125 E 17th Street Suite E210, Santa Ana, CA 92701

Certification for Nursing Assistant (February 2018)

Certification for CPR and AED (January 2018)

Secretary for Director – Certification (1998)

Foreign Language University, Hochiminh city, Vietnam

SKILLS

TECHNICAL SKILLS:

Laboratory skills

Operations supervisory skills

Microsoft Office skills

Quality 7 Tools application

Supplier and Customer Quality auditing

Lead Auditor in ISO22000/FSSC/ISO9000

ISO 9001/ 14001/ 22000/ 13485/ FSSC/ cGMP/ HACCP

Internal Auditor in ISO14000/OHSAS18000/ HACCP/cGMP

AIB Self Inspection and Integrated Pest Management

SOFT SKILLS:

Leadership

Effective Communication and Negotiation for Win-Win results

Problem solving and Decision making

Time management

Coaching

KAIZEN/ Statistical Process Control

Teamwork/ Team commitment

REFERENCES - Available upon request

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